Status:
COMPLETED
Evaluating the Safety and Efficacy of the Probiotic Bifidobacterium Longum ES1 and the Post Biotic Heat-treated Bifidobacterium Longum ES1 (HT-ES1) on IBS Symptom Severity in Patients With Diarrhoea Predominant Irritable Bowel Syndrome
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Randomized controlled clinical study has been proposed to evaluate the safety and efficacy of ES1 probiotic strain and heat-treated ES1 postbiotic strain in individuals suffering from IBS-D.
Eligibility Criteria
Inclusion
- Males and females aged ≥18 to ≤ 65 years.
- Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
- i) Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria: Related to defecation Associated with a change in stool frequency (increase/decrease in frequency). Associated with a change in the form (appearance) of stool. ii) History of abnormal bowel movements predominantly diarrhoea (\>25% of bowel movement categorised as stool form type 6 or 7 (diarrhoea) and \<25% as stool form type 1 or 2 constipation) on BSFS).
- Participants with an IBS-SSS score ≥ 175.
- Participants who test negative for COVID-19 by Rapid Antigen Lateral Flow Test Device.
- Participants who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
- Female participants who are willing to use acceptable contraceptives during the study duration.
- Participants who are literate enough to understand the purpose of the study and their rights.
- Participants who are able to give written informed consent and are willing to participate in the study.
Exclusion
- Participants diagnosed with anxiety as assessed by STAI-AD S- anxiety subscale score ≥ 40.
- Gluten and/or lactose intolerant individuals.
- Abnormal Thyroid Stimulating Hormone (TSH) value which is (\< 0.4 to \> 4.2 mIU/L).
- Participants with uncontrolled type II diabetes mellitus defined as random blood glucose (RBG) \> 199 mg/dL or fasting blood glucose (FBG) \>125 mg/dL.
- Participants with a body mass index (BMI) ≥ 30 kg/m2.
- Presence of uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg.
- Participants with a history of intake of antibiotics (Rifaximin, metronidazole, or any other), other probiotics, prebiotics, synbiotic, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), FODMAP diet, and histamine H2- receptor antagonists/H2 blockers within six weeks prior to the screening day.
- Participants with a history of daily intake of antidepressants (Tricyclic antidepressants, Selective serotonin reuptake inhibitors (SSRIs), and Selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs)), clonidine, otilonium bromide, asimadoline, eluxadoline, diphenoxylate, antispasmodics including mebeverine and pinnaverium and anticholinergics within two weeks before the screening day.
- Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
- Participants showing signs of bile acid malabsorption (BAM), as evident from the history of green colour or foul odour of the stool during the last month.
- Participants with a history of or complications from malignant tumours.
- Participation in other clinical trials in the last 90 days prior to screening
- Active smokers or using any form of smokeless tobacco.
- Participants with substance abuse problems (within two years) defined as:
- Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol- containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol- containing beverages per week for men.
- Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder, tumour, and other gastrointestinal diseases.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05339243
Start Date
April 21 2022
End Date
January 13 2023
Last Update
September 8 2023
Active Locations (8)
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1
Apex Gastro Clinic and Hospital
Ahmedabad, Gujarat, India, 380013
2
Gastroplus, Digestive disease centre
Ahmedabad, Gujarat, India, 380054
3
Aman Hospital and research centre
Vadodara, Gujarat, India, 390021
4
Shantaee Nursing Home
Mumbai, Maharashtra, India, -400067